NOxBOXi Nitric Oxide Delivery System
FDA Recall Z-2544-2025 · Posted 2025-09-09
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Recalling FirmNOXBOX LTD
Recall StatusOpen, Classified
Product CodeMRN
Date Initiated2023-07-19
Product Quantity1,667 units
Reason for Recall
Replacement of the internal Sample Pump due to high failure rates.
Firm Action
An email with the subject "New Internal Sampling Pump" was sent to consignees on 7/19/2023 notifying them that the internal Sampling Pump of NOxBOXi Nitric Oxide Delivery System devices was to be replaced. The replacement does not change the use of the device but does result in a quieter device functionality. This replacement will be conducted during annual servicing by Level 3 Service Engineers at authorized NOXBOX Service Centers. Consignees with any questions are to email [email protected] or their account manager.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide distribution in the state of TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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